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Topisulf Cream

Generic Name: sulfacetamide sodium and sulfur
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Topisulf Emollient Cream

INDICATIONS AND USAGE:

Topisulf Emollient Cream is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

DOSAGE AND ADMINISTRATION:

Apply Topisulf Emollient Cream to affected areas 1-3 times daily, or as directed by your doctor. First, cleanse your skin thoroughly before application. Second, apply a thin layer of Topisulf Emollient Cream to the affected areas as directed by your doctor. Finally, start using Topisulf Emollient Cream once daily to minimize dryness, then increase application frequency to 2-3 times daily or as directed by your doctor.

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WARNINGS AND PRECAUTIONS:

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraided skin are involved. Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. In addition, patients with kidney disease should not use Topisulf Emollient Cream.

Topisulf Emollient Cream
is for external use only. Avoid contact with the eyes, eyelids, lips, other mucous membranes and any damaged areas of the skin, such as wounds or open sores. If accidental contact with one of these areas occurs, rinse thoroughly with water.

Keep out of the reach of children.

ADVERSE REACTIONS:

Like any medication, Topisulf Emollient Cream may occasionally cause side effects in some people. Although uncommon, some possible side effects may include skin irritation such as redness, dryness, itching or swelling. If you experience excessive skin irritation, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

USE IN SPECIFIC POPULATIONS:

Pregnancy: Category C. Animal reproduction studies have not been conducted with Topisulf Emollient Cream. It is also not known whether Topisulf Emollient Cream can cause fetaI harm when administered to pregnant women or can affect reproduction capacity. Topisulf Emollient Cream should be given to pregnant women only if clearly needed.

Nursing Mothers: It is not known whether sodium sulfacetamide is excreted in the human milk following topicaI use of Topisulf Emollient Cream. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Topisulf Emollient Cream is administered to nursing women.

Pediatric Use: Safety and effectiveness in children under the age of 12 have not been established.

DESCRIPTION:

Topisulf Emollient Cream contains the following active ingredients: 10% Sodium Sulfacetamide and 5% Sulfur. Other inactive ingredients are Purified Water, Isopropyl Myristate NF, Propylene Glycol USP, Glyceryl Monostearate NF, Glyceryl Stearate and PEG 100 Stearate, Stearic Acid, Stearyl Alcohol and Ceteareth 20, Gum Arabic, Methylparaben, Disodium EDTA, Sodium Hyaluronate, Sodium Thiosulfate USP, Xanthan Gum, Baby Powder Fragrance, Propylparaben, Vitamin E Acetate, and Green Tea Extract.

CLINICAL PHARMACOLOGY:

Sodium sulfacetamide: The bacteria fighting action helps to block the overgrowth of the bacteria thought to be involved in acne development. Sulfur: The exfoliating properties help to promote the removal of dead cells from the top layer of skin.

NONCLINICAL TOXICOLOGY:

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential.

HOW SUPPLIED/STORAGE AND HANDLING:

Topisulf Emollient Cream should be stored between 20°–25°C (68°–77°F). Avoid exposing the products to excessive heat. Topisulf Emollient Cream is available in 1 oz tubes, NDC 49769-309-28.

Manufactured for:
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
309-10 Rev. 02/10 P0558

PACKAGING:

Below represents the current packaging being used:

Tube:

Carton:

TOPISULF 
sulfacetamide sodium, sulfur cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49769-309
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 g
SULFUR (SULFUR) SULFUR 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
ISOPROPYL MYRISTATE  
PROPYLENE GLYCOL  
GLYCERYL MONOSTEARATE  
GLYCERYL MONOSTEARATE  
STEARIC ACID  
STEARYL ALCOHOL  
ACACIA  
METHYLPARABEN  
EDETATE DISODIUM  
HYALURONATE SODIUM  
SODIUM THIOSULFATE  
XANTHAN GUM  
PROPYLPARABEN  
ALPHA-TOCOPHEROL ACETATE  
GREEN TEA LEAF  
Packaging
# Item Code Package Description
1 NDC:49769-309-28 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2010 11/30/2012
Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 03/2011
 
Kylemore Pharmaceuticals, LLC



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